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The Future of Drug Safety - Promoting and Protecting the Health of the Public (Paperback)
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The Future of Drug Safety - Promoting and Protecting the Health of the Public (Paperback)
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In the wake of publicity and congressional attention to drug safety
issues, the Food and Drug Administration (FDA) requested the
Institute of Medicine assess the drug safety system. The committee
reported that a lack of clear regulatory authority, chronic
underfunding, organizational problems, and a scarcity of
post-approval data about drugs' risks and benefits have hampered
the FDA's ability to evaluate and address the safety of
prescription drugs after they have reached the market. Noting that
resources and therefore efforts to monitor medications'
risk?benefit profiles taper off after approval, The Future of Drug
Safety offers a broad set of recommendations to ensure that
consideration of safety extends from before product approval
through the entire time the product is marketed and used. Table of
Contents Front Matter Summary 1 Introduction 2 Natural History of a
Drug 3 A Culture of Safety 4 The Science of Safety 5 Regulatory
Authorities for Drug Safety 6 Communicating About Safety 7
Resources for the Drug Safety System Appendix A Moving Target--The
Shifting Landscape of Drug Safety in the United States Appendix B
Acronyms Appendix C PDUFA Performance Goals-All Years Appendix D
Committee on the Assessment of the US Drug Safety System Meeting
Agendas Appendix E Summary: Preventing Medication Errors: Quality
Chasm Series, Institute of Medicine Appendix F Committee
Biographies Index
General
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